Company
GermanySivantos GmbH, Erlangen, Germany – FDA Inspections
Inspection records and compliance data for Sivantos GmbH in Erlangen. 3 FDA inspections on record, 1 Form 483, last inspected February 02, 2023.
Company Profile
This profile covers Sivantos GmbH based in Erlangen, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 31, 2013. Last inspected February 2, 2023.
Most cited issue areas
- Lack of System for Event Evaluations2 inspections
- Design review - Lack of or inadequate procedures1 inspection
- Design verification - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 2, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1196667 |
| May 17, 2018 | Not classified | Medical Devices & Rad Health | 1079959 |
| October 31, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 857143 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sivantos GmbH
FEI Number
3005019184
Address
Henri-Dunant-Str. 100, Erlangen, Germany
Country
Germany
ID: bbdf956b-4050-44c2-99f4-f5c12836cda7